# US 2026/0090986 A1 · Capsule inhaler for the administration of a phosphodiesterase-4 inhibitor

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- Number: US 2026/0090986 A1
- Document ID: US20260090986A1
- Status: Published application
- Kind: A1
- Application number: 19/112,650
- Filed: 2023-09-21
- Published: 2026-04-02
- Earliest claimed: 2022-09-22
- Assignees: Chiesi Farmaceutici S.p.A.
- Applicants: Chiesi Farmaceutici S.P.A.
- Inventors: Francesca BUTTINI; Giada VARACCA; Romina OSELLO
- Web page: https://patentgrep.com/patent/US20260090986A1

## CPC

- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 31/44: Non condensed pyridines; Hydrogenated derivatives thereof
- A61K 31/4425: Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61M 11/003: {by passing the aerosol trough sieves or filters}
- A61M 15/0021: {Mouthpieces therefor}
- A61M 15/003: {using capsules, e.g. to be perforated or broken-up}
- A61M 15/004: {with fixed piercing or cutting means}
- A61M 15/08: Inhaling devices inserted into the nose
- A61M 15/0035: {Piercing means}
- A61M 15/0041: {with movable piercing or cutting means}
- A61M 2202/064: Powder
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The present invention relates to a drug product comprising a single-dose dry powder inhalation device and a pharmaceutical composition filled in a capsule, the pharmaceutical composition comprising micronized particles of the compound of formula (I) and a carrier. The present invention also relates to a drug product or a pharmaceutical composition for use for the treatment of a respiratory disease and to a method for the treatment of a respiratory disease.

## Claims

### Claim at position 1

1: A drug product, comprising a single-dose dry powder inhalation device, comprising an inhaler body (2) defining a recess (3) for a capsule (4), wherein the capsule (4) holds herein a pharmaceutical composition to be inhaled, a nosepiece or mouthpiece (5) communicating with the recess (3), at least one rupturing element (7) coupled to the inhaler body (2) and configured for rupturing the capsule (4) to allow an outside airflow to be mixed with the pharmaceutical composition of the capsule (4) and inhaled through the nosepiece or the mouthpiece (5), and
a pharmaceutical composition filled in a capsule, the pharmaceutical composition comprising micronized particles having a size of from 0.1 to 15 microns of the compound of formula (I)
and a carrier consisting of a mixture of coarse and fine particles of pharmaceutically inert acceptable excipient,
wherein the inspiratory flow rate of said inhalation device is from 30 l/min to 65 l/min and
wherein the carrier consists of a mixture of coarse and fine particles of a physiologically acceptable inert excipient in a ratio comprised of from 70:30 to 95:5 by weight,
the coarse particles have an equivalent volume diameter of from 200 to 500 micron,
the fine particles have a dv(0.1) of from 1 to 5 μm, a dv(0.5) of from 18 to 30 μm, and a dv(0.9) of from 65 to 95 μm, as measured by means of laser diffraction or a sieve analyzer.

### Claim at position 2 (depends on 1)

2: The drug product according to claim 1, wherein the carrier is selected from the group consisting of a polyol, a crystalline sugar, an inorganic salt, an organic salt, an organic compound, a polysaccharide, and an oligosaccharide.

### Claim at position 3 (depends on 1)

3: The drug product according to claim 1, wherein the coarse particles have an equivalent volume diameter of from 300 to 480 micrometers.

### Claim at position 4 (depends on 3)

4: The drug product according to claim 3, wherein the coarse particles have an equivalent volume diameter of from 350 to 450 micrometers.

### Claim at position 5 (depends on 1)

5: The drug product according to claim 1, wherein the inspiratory flow rate is from 40 l/min to 65 l/min.

### Claim at position 6 (depends on 1)

6: The drug product according to claim 1, wherein the unitary nominal dose of the compound of formula (I) is from 400 to 800 μg.

### Claim at position 7 (depends on 6)

7: The drug product according to claim 6, wherein the unitary nominal dose of the compound of formula (I) is 400 μg.

### Claim at position 8 (depends on 6)

8: The drug product according to claim 6, wherein the unitary nominal dose of the compound of formula (I) is 800 μg.

### Claim at position 9

9: A method for the treatment of a respiratory disease, comprising administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising micronized particles having a size of from 0.1 to 15 microns of the compound of formula (I)
and a carrier for use for the treatment of a respiratory disease,
wherein said composition is administered using a single-dose dry powder inhalation device,
wherein the inspiratory flow rate of said inhalation device is from 30 l/min to 65 l/min, and
wherein the carrier consists of a mixture of coarse and fine particles of a physiologically acceptable inert excipient in a ratio comprised between 70:30 and 95:5 by weight,
the coarse particles have an equivalent volume diameter of from 200 to 500 microns, as measured by means of laser diffraction or a sieve analyzer,
the fine particles have a dv(0.1) of from 1 to 5 μm, a dv(0.5) of from 18 and 30 μm, and a dv(0.9) of from 65 and 95 μm, as measured by means of laser diffraction or a sieve analyzer.

### Claim at position 10 (depends on 9)

10: The method according to claim 9, wherein the respiratory disease is selected from asthma and chronic obstructive pulmonary disease (COPD).

### Claim at position 11 (depends on 9)

11: The method according to claim 9, wherein the total daily dose of the compound of formula (I) is from 800 to 4800 μg.

### Claim at position 12 (depends on 11)

12: The method according to claim 11, wherein the total daily dose of the compound of formula (I) is from 1600 to 3200 μg.

### Claim at position 13 (depends on 1)

13: A process for the preparation of the drug product according to claim 1, said process comprising:
i) sieving the compound of formula (I) through a suitable mesh,
ii) adding the carrier particles to the compound of formula (I),
iii) sieving the final blend and mixing to obtain the pharmaceutical composition,
iv) filling the obtained pharmaceutical composition in a capsule, and
v) loading the capsule into a medicament chamber of a single dry powder inhalation device.